BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 837414 · Received October 17, 2006

    Report

    Report Number
    1823260-2006-05955
    Event Type
    Malfunction
    Date Received
    October 17, 2006
    Date of Event
    September 18, 2006
    Report Date
    September 27, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT REPORTED OBTAINING A BLOOD GLUCOSE RESULT OF 280 MG/DL, WHILE USING THE SUSPECT DEVICE. PT INDICATED THAT, WITHIN 10 MINUTES, BLOOD GLUCOSE WAS RETESTED ON A PHYSICIAN'S DEVICE, WITH A RESULT OF 118 MG/DL. NO PT INJURY WAS REPORTED AND NO TREATMENT WAS REC'D. QC TESTING HAD NOT BEEN PERFORMED ON THE SUSPECT DEVICE. TECHNICAL SUPPORT REQUESTED THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT PRODUCT WAS SHIPPED. PT REPORTED OBTAINING A BLOOD GLUCOSE RESULT OF 280MG/DL, WHILE USING THE SUSPECT DEVICE. PT INDICATED THAT, WITHIN 10 MINS, BLOOD GLUCOSE WAS RETESTED ON A PHYSICIAN?S DEVICE, WITH A RESULT OF 118MG/DL. NO PT INJURY WAS REPORTED AND NO TREATMENT WAS REC?D. QC TESTING HAD NOT BEEN PERFORMED ON THE SUSPECT DEVICE. TECHNICAL SUPPORT REQUESTED THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT PRODUCT AS SHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIAGNOSTICS NA 549055

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR AVALIDE| GLIMEPIRIDE| HUMULIN N| ASPIRIN| VYTORIN| B-COMPLEX| METFORMIN| DIGITEK| THERAPY DATES| FEXOFENADINE| ACCU-CHECK ADVANTAGE BLOOD GLUCOSE MONITOR| COREG